Document Actions
Slide Presentations
Up one level- Pharmaceutical and
Device Development [pdf]
Supplements:
- IND Process and
Interacting with FDA [pdf]
- Clinical Studies and
Requirements for an IND [pdf]
- Regulations, ICH Guidelines and Good Clinical Practice (GCP): How do they fit together? [pdf]
- Overview of the Regulatory Environment [pdf]
- Regulatory Environment for the Approval of Diagnostic Tests [pdf]
- Introduction to
Clinical Research (short version), March 2008 [pdf]
- Introduction to
Clinical Research (long version), August 2009 [pdf]